IMANIB

What it is

IMANIB contains imatinib as the mesilate salt and is available as film-coated tablets in 100 mg and 400 mg strengths.

Approved indications —

Treatment of patients with chronic myeloid leukaemia (CML). — Treatment of adult and paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy. — Treatment of adult patients with relapsed or refractory Ph+ ALL as monotherapy. — Treatment of adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with platelet-derived growth factor receptor (PDGFR) gene re-arrangements, where conventional therapies have failed. — Treatment of adult patients with aggressive systemic mastocytosis (ASM), where conventional therapies have failed. — Treatment of adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukaemia (CEL). — Treatment of patients with KIT (CD117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (GIST). — Adjuvant treatment of adult patients at high risk of recurrence following complete gross resection of KIT (CD117)-positive primary GIST. — Treatment of adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP).

Dosing overview

Doses vary by indication and patient population. For chronic phase CML, the recommended dose is 400 mg daily; for accelerated phase or blast crisis CML, 600 mg daily. For Ph+ ALL, 600 mg daily is recommended. For MDS/MPD and ASM, initial doses are 400 mg daily. For HES/CEL, 400 mg daily is recommended. For GIST, doses of 400–600 mg daily are used for unresectable or metastatic disease, and 400 mg daily for adjuvant treatment. For DFSP, 800 mg daily is recommended. IMANIB should be administered orally with a meal and a large glass of water to minimise the risk of gastrointestinal disturbances. Doses of 400 mg or 600 mg should be administered once daily, whereas a daily dose of 800 mg should be administered as 400 mg twice a day.

Key safety warnings

If severe non-haematological adverse reactions develop, such as severe hepatotoxicity or severe fluid retention, IMANIB should be withheld until the event has resolved, after which treatment can be resumed as appropriate depending on the initial severity of the event. If elevations in bilirubin exceed 3 times the institutional upper limit of normal or liver transaminases exceed 5 times the institutional upper limit of normal, IMANIB should be withheld until levels normalise, and treatment may then be continued at a reduced daily dose. Dose reduction or treatment interruption for severe neutropenia and thrombocytopenia are recommended based on specified criteria.

Regulatory history

IMANIB was first registered on the Australian Register of Therapeutic Goods on 26 November 2015, with four ARTG entries covering 100 mg and 400 mg tablet formulations in blister and bottle pack presentations.